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Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation (TRE x ICR)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ICR (Intensive Cardiac Rehabilitation)

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Time Restricted Eating, Circadian Rhythm, Cardiac Rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-75 years
Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program
Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable)
Own a smartphone (Apple iOS or Android OS)
If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose adjustments will be allowed during the study period.

Exclusion Criteria:

Taking insulin within the last 6 months.
Known inflammatory and/or rheumatologic disease.
Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
Pregnant or breast-feeding women.
Shift workers with variable (e.g. nocturnal) hours.
Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
Planned international travel during study period.
Systolic HF alone.
Heart transplant within the past 1 year.
Presence of left ventricular assist device.
Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
History of adrenal disease.
History of malignancy undergoing active treatment, except non-melanoma skin cancer.
History of type I diabetes with ongoing insulin dependence.
History of eating disorders.
History of cirrhosis.
History of stage 4 or 5 chronic kidney disease or requiring dialysis.
History of HIV/AIDS.
Currently enrolled in a weight-loss or weight-management program. This does not include UC San Diego's Cardiac Rehabilitation Programs.
On a special or prescribed diet for other reasons (e.g. Celiac disease).
Currently taking any medication that is meant for, or has a known effect on, appetite.
Any history of surgical intervention for weight management.
Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Baseline eating window <14 hours per day as documented on mCC app.
Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).

Sites / Locations

Altman Clinical and Translational Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

ICR (Intensive Cardiac Rehabilitation)

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

Arm Description

20 patients will be randomly assigned to the standard of care group, which will receive the standard health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR" group.

20 patients will be randomly assigned to the Time-Restricted Eating (TRE) group which will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR x TRE" group.

Outcomes

Primary Outcome Measures

Change in Exercise Capacity (MetS)

Exercise Capacity

Secondary Outcome Measures

Change in LDL cholesterol

LDL cholesterol (mg/dL)

Change in non-HDL cholesterol

non-HDL cholesterol (mg/dL)

Change in Triglycerides

Triglycerides (mg/dL)

Full Information

NCT ID

NCT05014880

First Posted

August 13, 2021

Last Updated

May 9, 2023

Sponsor

University of California, San Diego

Collaborators

Salk Institute for Biological Studies, The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05014880

Brief Title

Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation

Acronym

TRE x ICR

Official Title

Impact of Time Restricted Eating on Exercise Capacity, Cardiometabolic Parameters, and Trimethylamine N-oxide (TMAO) Levels in Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2021 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Salk Institute for Biological Studies, The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to see if reducing the number of hours during which one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health (i.e. blood sugar levels and blood pressure). The study also aims to assess changes in exercise capacity and trimethylamine N-oxide (TMAO) levels in response to Time Restricted Eating (TRE) and Intensive Cardiac Rehabilitation (ICR) versus ICR alone. TMAO is a metabolite, or a substance, produced during digestion and metabolism. Preliminary data illustrates a correlation between high levels of TMAO and higher risk of cardiovascular disease and mortality. We will also be looking at participants' long-term cardiovascular health status after they complete the ICR program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Time Restricted Eating, Circadian Rhythm, Cardiac Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICR (Intensive Cardiac Rehabilitation)

Arm Type

Placebo Comparator

Arm Description

Arm Title

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

ICR (Intensive Cardiac Rehabilitation)

Intervention Description

Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program.

Intervention Type

Behavioral

Intervention Name(s)

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

Intervention Description

Participants in this arm will adhere to a daily, consistent 10-hour eating window while undergoing UCSD's 9-week ICR program to see if there is an improvement on cardiometabolic parameters.

Primary Outcome Measure Information:

Title

Change in Exercise Capacity (MetS)

Description

Exercise Capacity

Time Frame

Baseline and Week 1-9

Secondary Outcome Measure Information:

Title

Change in LDL cholesterol

Description

LDL cholesterol (mg/dL)

Time Frame

Baseline and Week 9

Title

Change in non-HDL cholesterol

Description

non-HDL cholesterol (mg/dL)

Time Frame

Baseline and Week 9

Title

Change in Triglycerides

Description

Triglycerides (mg/dL)

Time Frame

Baseline and Week 9

Other Pre-specified Outcome Measures:

Title

Change in TMAO levels

Description

TMAO levels (uM)

Time Frame

Baseline and Week 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18-75 years Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable) Own a smartphone (Apple iOS or Android OS) If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose adjustments will be allowed during the study period. Exclusion Criteria: Taking insulin within the last 6 months. Known inflammatory and/or rheumatologic disease. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse. Pregnant or breast-feeding women. Shift workers with variable (e.g. nocturnal) hours. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions. Planned international travel during study period. Systolic HF alone. Heart transplant within the past 1 year. Presence of left ventricular assist device. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria). History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion). History of adrenal disease. History of malignancy undergoing active treatment, except non-melanoma skin cancer. History of type I diabetes with ongoing insulin dependence. History of eating disorders. History of cirrhosis. History of stage 4 or 5 chronic kidney disease or requiring dialysis. History of HIV/AIDS. Currently enrolled in a weight-loss or weight-management program. This does not include UC San Diego's Cardiac Rehabilitation Programs. On a special or prescribed diet for other reasons (e.g. Celiac disease). Currently taking any medication that is meant for, or has a known effect on, appetite. Any history of surgical intervention for weight management. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness). Baseline eating window <14 hours per day as documented on mCC app. Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David T Van, BS

Phone

858-246-2342

ucsdresearchcoordinator@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Victoria A Green, BS

Phone

858-246-2406

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pam R Taub, MD

Organizational Affiliation

UC San Diego Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Altman Clinical and Translational Research Institute

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David T Van, BS

Phone

858-246-2342

ucsdresearchcoordinator@gmail.com

First Name & Middle Initial & Last Name & Degree

Victoria A Green, BS

Phone

858-246-2406

First Name & Middle Initial & Last Name & Degree

Pam R Taub, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation

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